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02/09 Rina Arun
Team Leader at United HR Solutions Pvt. Ltd.

Views:104 Applications:1 Rec. Actions:Recruiter Actions:1

Officer - Regulatory Affairs - Medical Device (7-10 yrs)

Ahmedabad/Gujarat Job Code: 29231

Position : Regulatory Affairs Officer

Qualification : Pharmacist, Bachelor/Master in Pharmacy or Pharmaceutical Science.

Work experience : 7-10 years- experience in regulatory affairs from reputed Medical Device organization.

- Experience in handling African countries is a requirement and other Asian/Latin region desirable. Experience with medical devices would be preferable candidate for the position.


Competences :

- Regulatory knowledge in handling pharmaceutical products as well as medical devices.

- Superior expertise in medical device regulations and reporting in different countries.

- Prepared and submitted Technical file applications with supporting documentation to qualify for CE marking certificate registration.

- Should possess adequate knowledge on MDD or MDR regulations and applicable standards.

- Reviewed medical device labelling and advertising materials for accuracy and completeness.

- Compiled and reviewed medical device registration data for different class of products.

- Experience of preparation and submission of CTD in different countries for ROW market.

- Experience in handling queries received from NDRA in compliance to regulatory requirement.

- Updated on various regulatory guidelines on WHO, EU, ICH and ISO standards.

- Should be energetic and passionate about work.

- Ability to maintain positive attitude when under pressure and in stressful situations.

- Good administrative skills.

- Experience in project management.

- Team player with good communication skills.

- Should be well structured and systematic.

Languages : Proficiency in English is required.

Duties/Responsibilities :

- Responsible for coordination with supplier for arranging documents timely for dossier compilation.

- Concurrent follow-up with Country Manager, Agent and NDRA for ongoing submissions.

- Responsible for preparation, review and dispatch of registration dossiers for pharmaceutical products and medical devices as per application guidelines.

- Responsible for samples dispatch and to provide information to CM and agents.

- Review of registration dossiers for Medical Devices products with labelling requirement.

- Ensure all activities related to Regulatory Affairs (RA) complies with SOPs and regulatory / customer requirements.

- Responsible for evaluation, response preparation with supporting documents from supplier to query received from NDRA within deadlines.

- Coordination with cross-functional dept. on regulatory assistance.

- Review of product layouts (labels, leaflets, SPCs) in line with regulatory guidelines pharmaceutical products and medical devices.

- Proactive and dedicated work on product registration ensuring meeting deadlines.

- To support activities within team and collaborate on the development of strategies, execution of projects and ad hoc tasks.

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